Recall Z-3108-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard IV START KIT NON-STERILE REF: KRIV26-02
| Date | Sep 14, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides |
| Root cause | Packaging process control |
| Action | On August 18, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an "Urgent Medical Device Recall Update" to affected consignees via email. The update was due to a revise recall strategy. Initial notification was sent on July 14, 2026. Avid ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified in TABLE 1. 2. Discontinue use of the BD ChloraPrep Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 3. FOR AVID KIT KRIV26-02, IV START KIT NON-STERILE, KIT LOT 1658437: Discard entire kit as it contains the contaminated componen |
| Quantity | 288 units |
| Distribution | US Nationwide distribution in the state of NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.